Laboratory organization within another organization

Fatima97

Starting to get Involved
Hello Everyone,
I have a question regarding the organization of the laboratory.
We are in a several ISO & other certificates certified company with a QMS responsible for these certifications. Currently we are working on ISO17025 accreditation of our lab. There was one person in QMS that was assigned this task to prepare for it with the laboratory team. That person claimed that according to the ISO17025 requirements, the whole lab organization has to be separated from their current organizational position, including themselves (the QMS person). and they worked on that with HR and successfully separated the organization. Now this person left the company, after almost finalizing all requirements with lab team, and their roles were divided to several persons, and the QMS part was assigned to the other QMS responsible. but we're wondering, if we left the organization of the lab separated from the factory organization, but the general QMS responsible takes on also this role, will that affect the accreditation?


for more clarification, the organization looks like this now:
CEO>General factory manager> Lab manager
CEO> Quality manager > QMS

old organization was
CEO>General factory manager> lab team within R&D organization
 

UncleFester

Involved In Discussions
You have to consider impartiality (section 4) and also the legal entity of the laboratory (section 5). Providing that you can demonstrate that your lab is not influenced by its customers (i.e. your own R&D organisation) and you define roles and responsibilities for management of the QMS then I don't see either structure giving any issues.
 

ennifer.fadell

Registered
Hello Everyone,
I have a question regarding the organization of the laboratory.
We are in a several ISO & other certificates certified company with a QMS responsible for these certifications. Currently we are working on ISO17025 accreditation of our lab. There was one person in QMS that was assigned this task to prepare for it with the laboratory team. That person claimed that according to the ISO17025 requirements, the whole lab organization has to be separated from their current organizational position, including themselves (the QMS person). and they worked on that with HR and successfully separated the organization. Now this person left the company, after almost finalizing all requirements with lab team, and their roles were divided to several persons, and the QMS part was assigned to the other QMS responsible. but we're wondering, if we left the organization of the lab separated from the factory organization, but the general QMS responsible takes on also this role, will that affect the accreditation?


for more clarification, the organization looks like this now:
CEO>General factory manager> Lab manager
CEO> Quality manager > QMS

old organization was
CEO>General factory manager> lab team within R&D organization
We don't have roles separated and have been recertified twice within my current organization. My manager (Quality) oversees the QMS qualifications for IATF 16949 and helping with corrective actions closure. I am a quality supervisor and serve as our gauge calibration manager and lead auditor as well. We both facilitate external audits and do quite well calibrating 500 active gauges in house.
 
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